Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088250
Company: SALIX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANUSOL HC HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/06/1984 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/19/1993 SUPPL-2 Labeling

Label is not available on this site.

03/06/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ANUSOL HC

CREAM;TOPICAL; 2.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALA-CORT HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 080706 CROWN LABS
ANUSOL HC HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 088250 SALIX PHARMS
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 089682 ACTAVIS MID ATLANTIC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 089414 FOUGERA PHARMS INC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 085025 PERRIGO NEW YORK
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 040879 RISING PHARMS INC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 088799 TARO
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 040503 VINTAGE PHARMS

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